Friday, April 22, 2011
Clark Havighurst, Still Unfair to the Working Class: Health Care Under the Affordable Care Act, SSRN
Jennifer A. Chandler, Autonomy and the Unintended Legal Consequences of Emerging Neurotherapies, Neuroscience/SSRN
Sara Rosenbaum, Medicaid and Access to the Courts, NEJM
Alicia Ouellette, Hearing The Deaf: Cochlear Implants, The Deaf Community, and Bioethical Analysis, SSRN/Valp. L.Rev.
Paul Krugman twists the knife lodged in the back of consumer driven health care in today's New York Times piece "Patients Are Not Consumers," available here. There are some highly quotable sections such as:
Here’s my question: How did it become normal, or for that matter even acceptable, to refer to medical patients as “consumers”? The relationship between patient and doctor used to be considered something special, almost sacred. Now politicians and supposed reformers talk about the act of receiving care as if it were no different from a commercial transaction, like buying a car — and their only complaint is that it isn’t commercial enough.
Thursday, April 21, 2011
One rare point of elite consensus is that the US needs to reduce health care costs. Frightening graphs expose America as a spendthrift outlier. The President's first OMB director tirelessly tried to "bend the cost curve." The President's opponents are even more passionate about austerity.
Journalists and academics support that political consensus. Andrew Sullivan calls health spending a "giant suck from the rest of the working economy." Gregg Bloche estimates that "the 30% of health care spending that's wasted on worthless care" is "about the price of the $700 billion mortgage bailout, squandered every year." He calls rising health spending an "existential challenge," menacing other "national priorities." Perhaps inspired by Children of the Corn, George Mason economist Robin Hanson compares modern medicine to a voracious brat:
King Solomon famously threatened to cut a disputed baby in half, to expose the fake mother who would permit such a thing. The debate over medicine today is like that baby, but with disputants who won’t fall for Solomon’s trick. The left says markets won’t ensure everyone gets enough of the precious medical baby. The right says governments produce a much inferior baby. I say: cut the baby in half, dollar-wise, and throw half away! Our “precious” medical baby is in fact a vast monster filling our great temple, whose feeding starves our people and future. Half a monster is plenty.
But when you scratch the surface of these sentiments, you have to wonder: is the overall level of health care spending really the most important threat facing the country? Is it one of the most important threats? There are many ways to raise revenue to pay for rising health costs. Aspects of the Affordable Care Act,like ACOs and pilot projects, are designed to help root out unnecessary care.
I am happy to join the crusade against waste. But why focus on total health spending as particularly egregious or worrisome? Let's explore some of the usual rationales.
Wednesday, April 20, 2011
On April 12th, Senators John Kerry and John McCain introduced the “Commercial Privacy Bill of Rights Act of 2011.” Whatever its limits (and there are some), the Act represents an important re-direction for U.S. privacy law. It also represents a noteworthy example of bi-partisanship that might actually result in Congressional action.
In 1973, the then-Department of Health, Education, and Welfare published a report that has become the basis for privacy laws all over the world—but not in the United States. The report, Records, Computers, and the Rights of Citizens, proposed a comprehensive privacy framework for what were then called “automated personal data systems.” The report was written “in response to growing concern about the harmful consequences that may result from uncontrolled application of computer and telecommunications technology to the collection, storage, and use of data about individual citizens.” It proposed a version of what have become known as Fair Information Practice Principles: transparency about record-keeping, access to records, purpose-limitation and use specification, rights to correct or maintain records, data integrity and security, and precautions to prevent misuse. Congress passed the Privacy Act in 1974, but applied privacy protections only to information possessed by the federal government, 5 U.S.C. § 552a, Public Law No. 93-579, (Dec. 31, 1974) Since that time, the U.S. (unlike the EU, for example) has taken a sectoral approach to privacy, applying different statutes and regulations to some types or holders of information such as health information or consumer credit information. The primary federal law applying to information collection generally is the Federal Trade Commission Act’s prohibition of unfair or deceptive trade practices. While this Act certainly provides some privacy protection, it was not designed for this purpose.
The Kerry-McCain Act rests on Fair Information Practice Principles: security and accountability; the right to notice, consent, access to and correction of information; data minimization; and data integrity. The Act would apply to all personally identifiable information and information stored in connection with personally identifiable information. There are exceptions for information obtained from public records and not merged with covered information, for information obtained from a public forum where information is voluntarily shared by individuals, and for information obtained from public media. “Sensitive personally identifiable information” is information that, if compromised, carries a significant risk of economic of physical harm, information related to medical conditions or health records, and information about religious affiliation.
The Act would require the FTC to engage in rule-making regarding security measures to be applied to covered information. It would require the implementation of a “privacy by design” framework by all entities covered by the Act to ensure the maintenance of data management processes proportional to the type of information collected. Protecting Consumer Privacy in an Era of Rapid Change: A Proposed Framework for Businesses and Policymakers (“Privacy by design” was proposed by the FTC staff in December, 2010. This report detailed the limits of “harm protection” and “notice and choice” methods for protecting privacy. It recommended consideration of a universal “do not track” mechanism for consumers to use in protecting themselves against tracking of their online behavior).
The Act would also require FTC rule-making to require all covered entities to provide consumers with clear notice of their privacy practices and to offer a clear and conspicuous mechanism for opt-out consent for any unauthorized use of personally identifiable information. Opt-in consent would be required for the collection, use, or transfer of sensitive personally identifiable information, with exceptions for services requested by the individual, fraud prevention, and security of the physical or virtual environment.
To be sure, there are concerns about the Act. It stops short of proposing a uniform do-not-track mechanism and thus may not provide mechanisms that are sufficiently easy for consumers to use. It encourages the establishment of safe harbors where participation is voluntary but the standards are as rigorous as those in the Act. Mechanisms such as these can become loopholes if they are not vigorously monitored and enforced. At the same time, the proposed Act represents a welcome step towards the comprehensive implementation of Fair Information Practice Principles that the U.S. proposed but stepped away from almost 40 years ago.
- Guest Blogger Leslie P. Francis
The Health Law Prof Blog is very proud to introduce our new guest blogger Professor Leslie P. Francis. Here is a short bio for Professor Francis:
Leslie P. Francis is Distinguished Professor of Law and Philosophy and Alfred C. Emery Professor of Law at the University of Utah. At Utah, she also holds adjunct appointments in the Division of Medical Ethics in the Department of Internal Medicine, in the Public Health program in the Department of Family Medicine, and in the Political Science Department. Francis received her Ph.D. in Philosophy from the University of Michigan in 1974 and her J.D from the University of Utah in 1981. She was a law clerk to Judge Abner Mikva of the United States Court of Appeals for the District of Columbia Circuit in 1981-82.
Professor Francis specializes in Ethics, Bioethics, Philosophy of Law, Health Law, and Disability Law. At present, she is leading the College of Law’s efforts to develop the Biolaw Project. Francis’s most recent books are The Patient as Victim and Vector: Ethics and Infectious Disease (with Margaret Battin, Jay Jacobson, and Charles Smith; Oxford University Press 2009); and the Blackwell Guide to Medical Ethics (edited with Rosamond Rhodes and Anita Silvers; Blackwell’s 2006). She also has edited (with Anita Silvers), Americans With Disabilities: Implications of the Law for Individuals and Institutions (Routledge, 2000). Articles published within the past year deal with topics such as syndromic surveillance, patient trust and electronic medical records, race and genetic discrimination, disability discrimination and access to health care, the intersection between disability discrimination and discrimination based on aged-ness, and federalism and the recognition of new legal rights. She is currently a member of the American Law Institute (elected 1986), the ethics committee of the American Society for Reproductive Medicine, and the National Committee on Health and Vital Statistics where she serves as cochair of the committee on Security, Privacy, and Confidentiality. In the spring of 2000, she was awarded the University of Utah’s Rosenblatt Prize for overall excellence in research, teaching, and academic service.
Nicholas P. Terry - Certification and Meaningful Use: Reframing Adoption of Electronic Health Records as a Quality Imperative
Nicholas P. Terry, Professor of Law at St. Louis University School of Law and blogger extraordinaire here at the Health Law Prof Blog, has posted - Certification and Meaningful Use: Reframing Adoption of Electronic Health Records as a Quality Imperative on SSRN. Here is the abstract:
This article examines the promise of the Health Information Technology for Economic and Clinical Health Act to reduce or eliminate the market failures that have impeded the adoption of electronic health records. Specifically, the article considers a key provision of the statute, a condition for receiving EHR subsidy funds: meaningful use. This deceptively simple requirement, that a health care provider must make “meaningful use of certified EHR technology,” has become both the regulatory core and the talisman for the next decade’s implementation of health information technology. The article describes the background to the subsidy program and examines the specifics of the “Certification” and “Meaningful Use” regulations that have followed. The article concludes by taking a broader view of Meaningful Use and relating it to the concept of more fundamental health care reform. [KVT]
This article examines the promise of the Health Information Technology for Economic and Clinical Health Act to reduce or eliminate the market failures that have impeded the adoption of electronic health records. Specifically, the article considers a key provision of the statute, a condition for receiving EHR subsidy funds: meaningful use. This deceptively simple requirement, that a health care provider must make “meaningful use of certified EHR technology,” has become both the regulatory core and the talisman for the next decade’s implementation of health information technology. The article describes the background to the subsidy program and examines the specifics of the “Certification” and “Meaningful Use” regulations that have followed. The article concludes by taking a broader view of Meaningful Use and relating it to the concept of more fundamental health care reform.
Monday, April 18, 2011
The Association of Climate Change Officers (ACCO) is hosting a conference on June 12-13 in Washington, DC entitled “Healthy Hospitals: Changing Climate in Healthcare Facilities and Institutions.” According to the conference website, it will consist of a series of interactive discussions examining opportunities to modernize healthcare institutions and facilities with respect to energy consumption, greenhouse gas emissions and improved patient response.
“Industry and government organizations in the healthcare sector are increasingly addressing the impacts of climate change and energy on operations. The sector is amongst the more intensive users of energy and natural resources in support of its operations. As energy costs rise and availability of natural resources declines, the healthcare community will face significant challenges and opportunities related to procurement, facilities management and design.
“Recent studies indicate a convergence of interests related to climate change, energy, and medical and global health. This workshop will examine the role of supply chain programs, green building design and retrofits, and facilities management in improving patient health and response to treatment, and reducing energy consumption, operational costs and greenhouse gas emissions.”
Invited speakers include Clayton Boenecke of the Office of the Assistant Secretary of Defense, Health Affairs, Gary Cohen, the President of Health Care Without Harm, Anna Gilmore Hall of Practice Greenhealth and many others. Kudos to ACCO for focusing the health care industry on the health of the planet.
Sadly, this is not a new story, but it may be getting worse. Most states have cut their mental health budgets, with outpatient services designed to prevent psychiatric crises being the hardest hit, although states also continue to trim the number of state psychiatric beds. They have done so notwithstanding that the need for mental health services continues to increase. See Ted Lutterman, NASMHPD Research Institute, Inc., The Impact of the State Fiscal Crisis on State Mental Health Systems Fall 2010 Update (Feb. 12, 2011).
Individuals experiencing acute psychiatric distress often approach the emergency department (ED) of a local hospital when they are in need of care, either because they need emergency services or because they lack adequate health care coverage and these are the only services available to them. Once there, however, they often experience extensive delays while waiting to obtain needed services.
Of course, it is not only this population that experiences such delays. The most recent findings of an ongoing national survey found that there were 117 million visits to hospital EDs in 2007, or 39 visits per 100 persons. This was an increase of 23% and 11%, respectively, over the past ten years. Citing a report by the Institute of Medicine, these changes were attributed to “an increase in ED visits along with a decrease in the number of EDs.” Citing a report by the Government Accountability Office, it was also noted that “the main issue contributing to overcrowding of EDs has been delays in moving the sickest patients to inpatient beds. Admitted patients have often been boarded in EDs or hospital hallways for hours to days, resulting in overcrowding and diversion of incoming ambulances to other hospitals.” Richard Niska et al., U.S. Dep’t Health & Human Services, Centers for Disease Control & Prevention, National Center for Health Statistics, National Hospital Ambulatory Medical Care Survey: 2007 Emergency Department Summary (Aug. 6, 2010).
But perhaps hardest hit by these delays are those individuals experiencing acute psychiatric distress. As a recent account noted:
Mentally ill patients often languish in hospital emergency rooms for several days, sometimes longer, before they can be moved to a psychiatric unit or hospital. At most, they get drugs but little counseling, and the environment is often harsh.
“The inside of the ER is kind of like Las Vegas,” with a “24/7, 365 flow of activity,” says Dr. Gary Bubly, an emergency physician . . . and president of the Rhode Island Medical Society. While the ER staff does its best to care for mentally ill patients, he says, it’s the wrong place for someone in the midst of a psychiatric crisis.
Jenny Gold, Mentally Ill Languish in Hospital Emergency Rooms, NPR, Apr. 13, 2011.
A 2010 survey by a firm that manages emergency departments across the country found that 70% of ED administrators report that they hold patients with a mental illness for twenty-four hours or longer, with 10% of them holding some patients for a week or more. In addition, 56% of the respondents said they were often unable to transfer “mental/behavioral patients” to inpatient facilities in a timely manner and another 30% said they were sometimes unable to do so, while only 3% said they were always able to transfer these patients in a timely fashion. Sixty percent of these administrators acknowledged that delays in transferring these patients compromises patient care in the ER. Schumacher Group, Emergency Department Challenges and Trends: 2010 Survey of Hospital Emergency Department Administrators 6 (2010).
These findings parallel those from a survey of ED directors released in 2008 by the American College of Emergency Physicians (ACEP). They also reported that such individuals can wait twenty-four hours or longer for an inpatient bed after being deemed to be in need of hospitalization, principally because of a lack of available psychiatric beds. Almost 80% said their hospital “boards” patients with a psychiatric disorder in the ED. This boarding may include placing the patient in an ED hallway, with 60% of these directors stating that their ED did not have a dedicated area for patients with a psychiatric disorder. The main reasons given for boarding were the lack of in-house inpatient psychiatric beds and no other facility being able or willing to accept transfers of these patients. Only half of the hospitals had psychiatric units, with the number of psychiatric beds in the community dropping 12% in the United States since 2000 (the number of hospital beds overall fell by 4% during this period). Hospitals were said to be closing their units because of inadequate payments from government and insurers, unpaid costs for the uninsured, and too few psychiatrists willing to work in hospitals.
The authors of this survey noted that a mental health specialist is rarely involved in the care of these boarded patients and the environment of a busy emergency department may exacerbate their symptoms, often requiring them to be sedated. The then-President of the ACEP noted that “‘[b]oarding’ is an appalling fact of life in our nation’s emergency departments, and too often our most vulnerable patients—psychiatric patients in this instance—bear the biggest burden.” She added that “[p]eople with psychiatric emergencies have nowhere else to turn, and they are suffering.” American College of Emergency Physicians, Psychiatric Patients, Including Children, Routinely Boarded in Emergency Departments (2008); Julie Appleby, Mentally Ill Face Extra-Long ER Waits, USA TODAY (June 16, 2008),
A Past President of the Emergency Nurses Association has written that:.
Providing safe and effective care for psychiatric patients in the emergency department (ED) has become an increasing challenge in recent years. Crowded, chaotic EDs have experienced a rising number of visits by patients in need of mental health services. . . . Despite this large number of visits, fewer than 20% of EDs have a mental health center. . . . Utilization of ED resources by psychiatric patients has reached crisis. . . . The chaotic physical environment in the ED may exacerbate the psychiatric patient’s behavior. . . . It is essential that the healthcare system recognizes the need to reduce the disparity of emergency care for psychiatric patients.
Patricia Howard, Psychiatric Care in the Emergency Department—Chaos or Crisis? Emergency Med. & Critical Care Rev. 41, 41-42 (2006). The President of the American Association of Emergency Psychiatry has expressed similar sentiments. Anthony T. Ng, Overcrowded Psychiatric Emergency Rooms, MIWatch.org: News About Mental Illness, Nov. 17, 2008. See also Alan Judd, Desperate Psychiatric Patients Wait: Some Wait Days in ERs, Get No Help, Atlanta-Journal Const., June 20, 2010 (“Hundreds of psychiatric patients have spent hours, days—as long as a week—in emergency rooms awaiting admission to state hospitals or other mental health facilities. . . . Few patients receive psychiatric care in the emergency rooms. Some get no more than a chair to sit through the delay.”).
Public attention was briefly focused on these issues when a woman by the name of Esmin Green collapsed and died unnoticed on the emergency room floor of a Brooklyn hospital after waiting for almost twenty-four hours for a psychiatric bed. For an account of what happened to Esmin Green, see Jim Dwyer, After a Death Seen on Tape, Change Is Promised, N.Y. Times, July 12, 2008; Anemona Hartocollis, Video of Dying Mental Patient Being Ignored Spurs Changes at Brooklyn Hospital, N.Y. Times, July 2, 2008. Excerpts of a recording made by the hospital’s surveillance camera that captures Ms. Green collapsing on the floor and being left unattended can be found here. For a description of the subsequent investigation into the services provided at the facility and the resulting findings, see Anemona Hartocollis, Abuse Is Found at Psychiatric Unit Run by City, N.Y. Times, Feb. 5, 2009. To review a copy of the report resulting from this investigation by the Civil Rights Division of the U.S. Department of Justice dated January, 20, 2009, see here. For an account of the wrongful death suit settlement reached between New York City and the family of Ms. Green, see Sewell Chan, City to Pay $2 Million in Death After Hospital Wait, N.Y. Times, May 28, 2009, at A24.
For other cases of interest that have addressed the liability of emergency departments for a failure to respond adequately to the needs of patients experiencing psychiatric distress, see Moses v. Providence Hsp. & Med. Ctrs., Inc., 561 F.3d 573 (6th Cir. 2009) (holding that a mental health emergency could qualify as an “emergency medical condition” under EMTALA, that the patient’s behavior and statements provided sufficient evidence to raise the possibility that the patient was experiencing a mental health emergency when he came to the hospital, and that there was evidence that the hospital physicians believed the patient had an emergency medical condition when he was discharged and that the discharge decision was driven by the unwillingness of the patient’s insurance plan to provide coverage); Card v. Amisub (SFH) Inc., No. 03-2528, 2006 WL 889430 (W.D. Tenn. Mar. 30, 2006) (ruling that a patient who sought “medical care to avert danger of harm to himself due to depression, suicidal tendencies, and substance and alcohol abuse” can proceed with his EMTALA and medical malpractice claims where an emergency room employee recommended that the man call an outpatient treatment center for services and gave him a list of such centers, the patient called each center on the list but was refused treatment by each because of his health insurance status, and the hospital employee then told the patient “they had done all they could possibly do” and subsequently discharged the patient from the hospital, after which the patient attempted to kill himself).
--Thomas L. Hafemeister